Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 December 2000 to 15 January 2001 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2001-01-26
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

26.1.2001

EN

Official Journal of the European Communities

C 26/5

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 December 2000 to 15 January 2001

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93 (1))

(2001/C 26/04)

(cid:151) Issuing of a marketing authorisation (Article 12 of Regulation (EEC) No 2309/93): Accepted

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

28.12.2000

Trizivir

15.1.2001

Allex

15.1.2001

Opulis

15.1.2001

Aerius

15.1.2001

Neoclarityn

15.1.2001

Azomyr

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels

EU/1/00/156/001-003

2.1.2001

EU/1/00/159/001-013

18.1.2001

EU/1/00/158/001-013

18.1.2001

EU/1/00/160/001-013

18.1.2001

EU/1/00/161/001-013

18.1.2001

EU/1/00/157/001-013

18.1.2001

(cid:151) Modification of a marketing authorisation (Article 12 of Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

18.12.2000

Forcaltonin

Unigene UK Limited
63 High Road
Bushey Heath
Herts WD2 1EE
United Kingdom

EU/1/98/093/001-002

19.12.2000

18.12.2000

Patrex

Roerig Farmaceutici SpA
Strada Statale, 156, km 50
I-04010 Borgo S. Michele (Latina)

EU/1/98/078/001-012

19.12.2000

18.12.2000

Triacelluvax

Chiron SpA
Via Fiorentina, 1
I-53100 Sienne

EU/1/98/088/001-009

19.12.2000

(1) OJ L 214, 24.8.1993, p. 1.

C 26/6

EN

Official Journal of the European Communities

26.1.2001

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

18.12.2000

Prometax

18.12.2000

Prometax

27.12.2000

Vitrasert

27.12.2000

Refacto

27.12.2000

Invirase

27.12.2000

Zyprexa Velotab

27.12.2000

Zyprexa

27.12.2000

Combivir

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 4AB
United Kingdom

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 4AB
United Kingdom

Dr. Gerhard Mann
Chem.-pharm. Fabrik GmbH
Brunsb(cid:252)tteler Damm 165(cid:151)173
D-13581 Berlin (Spandau)

Genetics Institute of Europe BV
Fraunhoferstra(cid:223)e 15
D-82152 Planegg/Martinsried

Roche Registration Ltd
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

Eli Lilly Nederland BV
Krijtwal 17-23
3432 ZT Nieuwegein
Netherlands

Eli Lilly Nederland BV
Krijtwal 17-23
3432 ZT Nieuwegein
Netherlands

Glaxo Group Ltd
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/98/092/001-002

19.12.2000

EU/1/98/092/013

19.12.2000

EU/1/97/034/001

29.12.2000

EU/1/99/103/001-003

29.12.2000

EU/1/96/026/001

2.1.2001

EU/1/99/125/001-004

2.1.2001

EU/1/96/022/012-015

2.1.2001

EU/1/98/058/001-002

28.12.2000

28.12.2000 Avonex

Biogen France SA
55, avenue des Champs-Pierreux
F-92012 Nanterre Cedex

EU/1/97/033/001

2.1.2001

28.12.2000

Taxotere

Aventis Pharma SA
20, avenue Raymond-Aron
F-92165 Antony Cedex

EU/1/95/002/001-002

2.1.2001

28.12.2000 Olansek

28.12.2000 Zyprexa

Eli Lilly UK Ltd
Kingsclere Road
Basingstoke
Hampshire
United Kingdom

Eli Lilly Nederland BV
Krijtwal 17-23
3432 ZT Nieuwegein
Netherlands

EU/1/96/021/001-010

2.1.2001

EU/1/96/022/001-011

2.1.2001

26.1.2001

EN

Official Journal of the European Communities

C 26/7

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

29.12.2000

Rilutek

29.12.2000 Gonal F

Aventis Pharma SA
20, avenue Raymond-Aron
F-92165 Antony Cedex

Ares-Serono (Europe)
24 Gilbert Street
London W1Y 1RJ
United Kingdom

EU/1/96/010/001

8.1.2001

EU/1/95/001/001-020

2.1.2001

15.1.2001

Plavix

Sanofi Pharma Bristol-Myers Squibb SNC
174, avenue de France
F-75013 Paris

EU/1/98/069/001a-001b-
002a-002b-003a-003b

17.1.2001

15.1.2001

Iscover

15.1.2001

Karvea

Bristol-Myers Squibb Pharma EEIG
Swakeleys House
Milton Road
Ickenham UB10 8PU
United Kingdom

Bristol-Myers Squibb Pharma EEIG
Swakeleys House
Milton Road
Ickenham UB10 8PU
United Kingdom

EU/1/98/070/001a-001b-
002a-002b-003a-003b

17.1.2001

EU/1/97/049/001-009

17.1.2001

15.1.2001

Aprovel

Sanofi Pharma Bristol-Myers Squibb SNC
174, avenue de France
F-75013 Paris

EU/1/97/046/001-009

17.1.2001

15.1.2001

Puregon

NV Organon
Kloosterstraat 6
Postbus 20
5340 BH Oss
Netherlands

EU/1/96/008/001-039

18.1.2001

15.1.2001

Ammonaps

Orphan Europe
Immeuble (cid:145)Le Guillaumet(cid:146)
F-92046 Paris-La DØfense

EU/1/99/120/001-004

17.1.2001

(cid:151) Modification of a marketing authorisation (Article 34 of Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

20.12.2000

Ibaflin

Intervet International BV (NL)
Wim de K(cid:246)rverstraat 35
5831 AN Boxmeer
Netherlands

EU/2/00/022/001a,001b,
002a,002b,003a,003b,
004a,004b,005,006,007,
008

22.12.2000

28.12.2000

Fevaxyn Pentofel

Fort Dodge Laboratories Ireland
Finisklin Industrial Estate
Sligo
Ireland

EU/2/96/002/001-003

3.1.2001

C 26/8

EN

Official Journal of the European Communities

26.1.2001

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

28.12.2000 Halocur

Intervet International BV (NL)
Wim de K(cid:246)rverstraat 35
5831 AN Boxmeer
Netherlands

EU/2/99/013/001-002

2.1.2001

(cid:151) Suspension of a marketing authorisation (Article 40 of Regulation (EEC) No 2309/93)

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

20.12.2000

Econor

Novartis Animal Health Austria GmbH
Biochemiestra(cid:223)e 10
A-6250 Kundl

EU/2/98/010/001-024

22.12.2000

Anyone wishing to consult the public assessment report on the medicinal products in question and the
decisions relating thereto is invited to contact:

The European Agency for the Evaluation of Medicinal Products
7 Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom.

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 December 2000 to 15 January 2001

(Decisions taken pursuant to Article 14 of Directive 75/319/EEC (1) or Article 22 of Directive 81/851/EEC (2))

(2001/C 26/05)

(cid:151) Issuing of a national marketing authorisation

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the marketing authorisation

Member State concerned

Date of
notification

27.12.2000

KØtoprofŁne
Ethypharm LP

See Annex

See Annex

28.12.2000

(1) OJ L 147, 9.6.1975, p. 13; as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).
(2) OJ L 317, 6.11.1981, p. 1; as last amended by Directive 93/40/EEC (OJ L 214, 24.8.1993, p. 31).